Carcinoma, Non-Small-Cell LungPhase 2NCT03802058
Concurrent Nab-P/Carboplatin and Thoracic Radiotherapy in Squamous Cell Lung Cancer
A Phase 2 study testing Nab-paclitaxel, Carboplatin and Thoracic radiation therapy in people with Carcinoma, Non-Small-Cell Lung and Squamous Cell Carcinoma, run by Wuhan University at 1 site in China.
Trial summary
Nab-paclitaxel and carboplatin showed better treatment response compared with cremophor-based paclitaxel and carboplatin as first-line therapy in advanced non-small cell lung cancer, especially for squamous cell cancer. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung, Squamous Cell Carcinoma
- What is being tested?
- Nab-paclitaxel, Carboplatin and Thoracic radiation therapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 20 Mar 2019to 12 Dec 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 18 Years to 70 Years
- Performance status of 0 to 1 on the Eastern Cooperative Oncology Group (ECOG) Scale.
- Previously untreated, histological documented, inoperable stage III squamous cell carcinoma of lung, excluding those with pericardial, pleural effusion, and those with contralateral hilar or contralateral supraclavicular lymph nodes.
- Patients must have measurable disease according to RECIST criteria, and all detectable tumor can be encompassed by radiation therapy fields.
- Patient must have adequate blood, liver, lungs and kidney function within the requirements of this study.
- Female patients of child-bearing potential must test negative for pregnancy at the time of enrollment based on a serum pregnancy test. Male and female patients must agree to use a reliable method of birth control during and for 3 months following the last dose of study drug.
- Patients must sign a study-specific informed consent form prior to study entry.
Who cannot join
- Complete tumor resection, recurrent disease, or those patients eligible for definitive surgery.
- Previous chemotherapy or previous biologic response modifiers for current lung cancer.
- Patient has previously had thoracic radiation therapy.
- Prior or concurrent malignancy except non-melanomatous skin cancer unless disease-free for five years or more.
- Serious concomitant disorders that would compromise the safety of the patient, or compromise the patient's ability to complete the study, at the discretion of the investigator.
- History of significant neurological or mental disorder, including seizures or dementia.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Concurrent Nab--paclitaxel/Carboplatin and Thoracic Radiotherapy in Inoperable Stage III Squamous Cell Lung Cancer
Nab-paclitaxel and carboplatin showed better treatment response compared with cremophor-based paclitaxel and carboplatin as first-line therapy in advanced non-small cell lung cancer, especially for squamous cell cancer. This study is conducted to evaluate the efficacy and safety of nab-paclitaxel, carboplatin and concurrent radiotherapy in patients with local advanced inoperable squamous cell lung cancer.
Read the detailed description
This study was conducted to explore the efficacy and safety of concurrent concurrent nab-paclitaxel, carboplatin and thoracic radiotherapy in inoperable local advanced squamous cell lung cancer. Patients will be given nab-paclitaxel weekly at a dose of 40mg/m2, in combination with carboplatin (AUC 2) weekly during concurrent chemoradiotherapy. Thoracic radiation was administered at a dose of 60-66 Gy/30-33 fractions, both 3 dimensional conformal and intensity modulated radiation therapy are allowed.
- Being tested
- Nab-paclitaxel, Carboplatin, Thoracic radiation therapy
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Carcinoma, Squamous Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nab-paclitaxelDrug
Also called Nab-P
Nab-paclitaxel 40mg/m2 for Injection weekly
CarboplatinDrug
Also called CBP
Carboplatin AUC=2 for Injection weekly
Thoracic radiation therapyRadiation
Also called RT
Thoracic radiation therapy 60-66Gy/30-33 fractions,both three-dimensional conformal and intensity modulated radiation therapy are allowed
| Study group | Role | What they receive |
|---|---|---|
| Nab-paclitaxel | Experimental | Nab-paclitaxel and carboplatin for Injection; thoracic radiation therapy Receives: Drug: Nab-paclitaxel; Drug: Carboplatin; Radiation: Thoracic radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS (progression-free survival )
PFS is defined as time from the start of treatment to death, progression of disease, or the last follow-up data, whichever comes first. Progression is evaluated using Response Evaluation Criteria In Solid Tumors (RECIST) 1.1. PFS will be analyzed using the Kaplan-Meier method.
Measured: 5 years from patient enrollment
Secondary outcomes (5)
ORR (Overall Response Rate )
The number of participants that achieve either a complete response (CR) or a partial response (PR). Response is evaluated using Response Evaluation Criteria In Solid Tumors (RECIST) 1.1.
Measured: one month after the end of all treatment
LCR (Local Control Rate)
The number of participants that achieve either a complete response (CR) , a partial response (PR) or stable disease(SD).
Measured: one month after the end of all treatment
OS (Overall survival)
Overall survival is defined as time from the start of treatment until death. Overall survival will be analyzed using the Kaplan-Meier method.
Measured: 5 years from patient enrollment
Number of participants with adverse events as assessed by CTCAE v4.0
The adverse events(AE) is evaluated by National Cancer Institute- Common Terminology Criteria for Adverse Events(NCI -CTCAE) 4.02.
Measured: 5 years from patient enrollment
Patient quality of life (QOL)
Measured by the Functional Assessment of Cancer Therapy - Lung (FACT-L).The total range of scores:0-144,and higher values represent a better outcome.
Measured: 5 years from patient enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2019
- Study start20 Mar 2019
- Primary completion12 Dec 2021
- Study completion12 Dec 2021
Why it stopped: The study was halted because enrollment was too slow
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Non-Small-Cell LungStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wuhan University
- Sponsor type
- University, hospital or other
- Collaborators
- CSPC Ouyi Pharmaceutical Co., Ltd.
- Responsible party
- Principal investigator, Conghua Xie,MD,PhD, Wuhan University
- Investigators
- Conghua Xie, Dr, Principal investigator, Wuhan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03802058
- Sponsor's protocol ID
- Nab-P RT
- Status last verified
- Apr 2023
- First submitted
- 6 Jan 2019
- Last updated
- 28 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all IPD can be shared by all researchers who participate in this study by e-mail contact
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Concurrent Nab--paclitaxel/Carboplatin and Thoracic Radiotherapy in Inoperable Stage III Squamous Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT03802058
- Acronym / sponsor ID
- Nab-P RT
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was halted because enrollment was too slow
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Wuhan UniversityUniversity, hospital or other
- Collaborators
- CSPC Ouyi Pharmaceutical Co., Ltd.
- Study start
- 20 Mar 2019 (actual)
- Primary completion
- 12 Dec 2021 (actual)
- Study completion
- 12 Dec 2021 (actual)
- First posted
- 14 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Nab-paclitaxel and carboplatin showed better treatment response compared with cremophor-based paclitaxel and carboplatin as first-line therapy in advanced non-small cell lung cancer, especially for squamous cell cancer. This study is conducted to evaluate the efficacy and safety of nab-paclitaxel, carboplatin and concurrent radiotherapy in patients with local advanced inoperable squamous cell lung cancer.
Detailed description
This study was conducted to explore the efficacy and safety of concurrent concurrent nab-paclitaxel, carboplatin and thoracic radiotherapy in inoperable local advanced squamous cell lung cancer. Patients will be given nab-paclitaxel weekly at a dose of 40mg/m2, in combination with carboplatin (AUC 2) weekly during concurrent chemoradiotherapy. Thoracic radiation was administered at a dose of 60-66 Gy/30-33 fractions, both 3 dimensional conformal and intensity modulated radiation therapy are allowed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nab-paclitaxel | Experimental | Drug: Nab-paclitaxel, Drug: Carboplatin, Radiation: Thoracic radiation therapyNab-paclitaxel and carboplatin for Injection; thoracic radiation therapy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age: 18 Years to 70 Years
- Performance status of 0 to 1 on the Eastern Cooperative Oncology Group (ECOG) Scale.
- Previously untreated, histological documented, inoperable stage III squamous cell carcinoma of lung, excluding those with pericardial, pleural effusion, and those with contralateral hilar or contralateral supraclavicular lymph nodes.
- Patients must have measurable disease according to RECIST criteria, and all detectable tumor can be encompassed by radiation therapy fields.
- Patient must have adequate blood, liver, lungs and kidney function within the requirements of this study.
Key exclusion criteria (6 listed)
- Complete tumor resection, recurrent disease, or those patients eligible for definitive surgery.
- Previous chemotherapy or previous biologic response modifiers for current lung cancer.
- Patient has previously had thoracic radiation therapy.
- Prior or concurrent malignancy except non-melanomatous skin cancer unless disease-free for five years or more.
- Serious concomitant disorders that would compromise the safety of the patient, or compromise the patient's ability to complete the study, at the discretion of the investigator.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nab-paclitaxelAlso: Nab-PNab-paclitaxel 40mg/m2 for Injection weekly | Drug | Nab-paclitaxel |
| CarboplatinAlso: CBPCarboplatin AUC=2 for Injection weekly | Drug | Nab-paclitaxel |
| Thoracic radiation therapyAlso: RTThoracic radiation therapy 60-66Gy/30-33 fractions,both three-dimensional conformal and intensity modulated radiation therapy are allowed | Radiation | Nab-paclitaxel |
Primary outcome
PFS (progression-free survival )
Time frame: 5 years from patient enrollment
PFS is defined as time from the start of treatment to death, progression of disease, or the last follow-up data, whichever comes first. Progression is evaluated using Response Evaluation Criteria In Solid Tumors (RECIST) 1.1. PFS will be analyzed using the Kaplan-Meier method.
5 secondary outcomes
ORR (Overall Response Rate )
Time frame: one month after the end of all treatment
LCR (Local Control Rate)
Time frame: one month after the end of all treatment
OS (Overall survival)
Time frame: 5 years from patient enrollment
Number of participants with adverse events as assessed by CTCAE v4.0
Time frame: 5 years from patient enrollment
Patient quality of life (QOL)
Time frame: 5 years from patient enrollment
Results and safety
The study was stopped early (reason given: The study was halted because enrollment was too slow). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2023.
- Individual participant dataSharing planned: Yes. all IPD can be shared by all researchers who participate in this study by e-mail contact
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Conghua Xie, Dr principal investigator
Wuhan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nab-paclitaxel, Carboplatin and Thoracic radiation therapy in people with Carcinoma, Non-Small-Cell Lung and Squamous Cell Carcinoma, run by Wuhan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The study was halted because enrollment was too slow). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (progression-free survival ) (time frame: 5 years from patient enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2023.